EP2994115A1 - Dosage projectile for remotely treating an animal - Google Patents
Dosage projectile for remotely treating an animalInfo
- Publication number
- EP2994115A1 EP2994115A1 EP14794581.0A EP14794581A EP2994115A1 EP 2994115 A1 EP2994115 A1 EP 2994115A1 EP 14794581 A EP14794581 A EP 14794581A EP 2994115 A1 EP2994115 A1 EP 2994115A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- animal
- agents
- dosage
- projectile
- projectile according
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61D—VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
- A61D7/00—Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
- A61K8/0241—Containing particulates characterized by their shape and/or structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
- A61K8/04—Dispersions; Emulsions
- A61K8/06—Emulsions
- A61K8/062—Oil-in-water emulsions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/58—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing atoms other than carbon, hydrogen, halogen, oxygen, nitrogen, sulfur or phosphorus
- A61K8/585—Organosilicon compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
- A61K8/81—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions involving only carbon-to-carbon unsaturated bonds
- A61K8/8141—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by only one carboxyl radical, or of salts, anhydrides, esters, amides, imides or nitriles thereof; Compositions of derivatives of such polymers
- A61K8/8152—Homopolymers or copolymers of esters, e.g. (meth)acrylic acid esters; Compositions of derivatives of such polymers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
- A61K8/84—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions otherwise than those involving only carbon-carbon unsaturated bonds
- A61K8/89—Polysiloxanes
- A61K8/895—Polysiloxanes containing silicon bound to unsaturated aliphatic groups, e.g. vinyl dimethicone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q19/00—Preparations for care of the skin
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F42—AMMUNITION; BLASTING
- F42B—EXPLOSIVE CHARGES, e.g. FOR BLASTING, FIREWORKS, AMMUNITION
- F42B12/00—Projectiles, missiles or mines characterised by the warhead, the intended effect, or the material
- F42B12/02—Projectiles, missiles or mines characterised by the warhead, the intended effect, or the material characterised by the warhead or the intended effect
- F42B12/36—Projectiles, missiles or mines characterised by the warhead, the intended effect, or the material characterised by the warhead or the intended effect for dispensing materials; for producing chemical or physical reaction; for signalling ; for transmitting information
- F42B12/40—Projectiles, missiles or mines characterised by the warhead, the intended effect, or the material characterised by the warhead or the intended effect for dispensing materials; for producing chemical or physical reaction; for signalling ; for transmitting information of target-marking, i.e. impact-indicating type
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F42—AMMUNITION; BLASTING
- F42B—EXPLOSIVE CHARGES, e.g. FOR BLASTING, FIREWORKS, AMMUNITION
- F42B12/00—Projectiles, missiles or mines characterised by the warhead, the intended effect, or the material
- F42B12/02—Projectiles, missiles or mines characterised by the warhead, the intended effect, or the material characterised by the warhead or the intended effect
- F42B12/36—Projectiles, missiles or mines characterised by the warhead, the intended effect, or the material characterised by the warhead or the intended effect for dispensing materials; for producing chemical or physical reaction; for signalling ; for transmitting information
- F42B12/46—Projectiles, missiles or mines characterised by the warhead, the intended effect, or the material characterised by the warhead or the intended effect for dispensing materials; for producing chemical or physical reaction; for signalling ; for transmitting information for dispensing gases, vapours, powders or chemically-reactive substances
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
- A61K2800/41—Particular ingredients further characterized by their size
- A61K2800/412—Microsized, i.e. having sizes between 0.1 and 100 microns
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
- A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
- A61K2800/49—Solubiliser, Solubilising system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
- A61K9/0017—Non-human animal skin, e.g. pour-on, spot-on
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
Definitions
- the invention relates to dosage projectiles for delivering an active agent to an animal.
- the invention relates to dosage projectiles that shatter on impact with an animal to produce fragments that remain associated with the animal to mark the impact site.
- a number of prior art treatment systems require del ivery of an active agent by piercing the skin or tissue. Although these devices can effectively deliver the desired treatment, often the animal is exposed to the potential of post-treatment infections at the site of delivery. An additional problem with many of the prior art methods is that it can be difficult to determine or monitor which animal has been treated.
- Known methods for remotely delivering agents to animals or humans can involve providing of aerosols in close proximity to the animal or person to be treated from a projectile that does not penetrate the skin or tissue.
- the use of aerosols cannot deliver a defined dosage of an active agent.
- WO 2008/0522631 in the nam ⁇ of Smartvet Pfy Ltd describes a remote treatment delivery system comprising a dosage projectile containing an active agent and a
- the projectile will split or rupture on contact with an animal and the contents of the projectile, which may include a marker, will be transferred to the animal white the projectile shell fails away, in some cases, depending on the nature of the marker and the colour of the anima! it can be difficult to determine which animals have been treated, particularly if the animals are viewed from a distance.
- the marker is contained within the projectile and is in solution with the active agent this restricts the choice and amount of marker to those that do not unduly reduce the efficacy of the active agent.
- the present inventor has developed a dosage projectile which is configured to fragment on impact with an animal and leave at least some of these fragments of the shell on the skin or fur of the animal to produce a visible mark on the animal at the site of impact.
- the invention provides a dosage projectile for administering an active agent to an animal, the projectile having a frangible shell configured to contain an active agent and adapted to fragment on impact with an animal to deliver the active agent to the antma! and produce a plurality of shell fragments associated with the antmai after impact to provide a visible mark on the animal.
- the visible mark allows determination of which animal in a herd of group of animals has been treated.
- the dosage projectile is substantially non-skin piercing.
- the frangible shell may be made of plasticized gelatine and sugar alcohol, polystyrene or polystyrene derivatives, hydrophilic colioidal materials, potyoiefins such as polypropylene or polyethylene, polycarbonate, polyamide, polyvinylchioride, resinous compounds, thermoplastic polyesters such as polylactic acid, thermoplastic starch polymer blends, or combinations thereof.
- any known plasticized gelatine and sugar alcohoi may be suitable for manufacturing the dosage projectile.
- the sugar alcohol may be from glycol, glycerol, erythritol, threitol, arabitol, xylitoi, ribitol, mannitol, sorbitol, galactitol, fucitoi, iditoi, inositol, volemito!, isomalt, maltitol, lactitol, maltotriito!, maltotetraito!, polyglycitol or combinations thereof.
- the frangible shell is biodegradable.
- the anhydrous shell composition may include from about 20% to 70% of a polyol or polyol blend, including but not limited to, glycerol, maltitol, xylitoi, sorbitol, sorbitan, propylene glycol, polyethylene glycol, and mannitol.
- the gelatin polymer composition may contain from 1% to 5% additives including colorants, opacifiers, lubricants, and antifoam agents.
- the frangible shell may contain or be coated with a marker.
- the marker may be selected from a water insoluble dye, water soluble dye, pigment, Lake dye, infra-red dye, ultraviolet dye, a luminescent dye, coloured paint, reflective, refractive, fluorescent or luminescent material.
- the shell fragments may be refractive, reflective, coloured, fluorescent, or luminescent.
- the shell fragments mark the animal for a period of time to allow confirmation that an animal has been treated. For example, a period of about 20 minutes to 3 hours may be suitable. In some embodiments marking is for up to about 72 hours can be desirable.
- the dosage projectile is capable of being remotely delivered over a distance.
- the active agent may be a pharmaceutical, veterinary pharmaceutical, vaccine or immunogenic compound, parasiticide,, pesticide, or health supplement.
- the pharmaceutical or veterinary pharmaceutical can be macrocyclic lactones, synthetic pyrethroids, insect growth regulators, anthelmintics, steroid hormones, anaesthetic agents and analgesics, antibacterial or antibiotic agents, anthelmintic, anti-trematodal, anticestodal, anti-parasitic/parasiticidal agents, acaricidal agents, anti-fungal agents, antihistamine agents, antiviral agents, anxiolytic agents, ⁇ - adrenergic agonists, bronchodilators, anti-allergy agents, cardioactive agents, central nervous system stimulants and agents, cholinergic agents, anti-cholinergic agents, antiemetic agents, or muscle relaxants.
- the health supplement can be a vitamin or mineral.
- the pharmaceutical or veterinary pharmaceutical may be a macrocyclic lactone such as ivermectin, eprinomectin, rnoxidectin, selamecttn, doramectin, miibemycin, abamectin, cydectin and emamectin benzoate.
- a macrocyclic lactone such as ivermectin, eprinomectin, rnoxidectin, selamecttn, doramectin, miibemycin, abamectin, cydectin and emamectin benzoate.
- the pesticide is a synthetic pyrethroid such as lambda cyhalothrtn, flumethrin, deltamethrin, cypermethrin, cyfluthrin, fenvaierate,
- the pesticide is an insect growth regulator such as pyriproxifen, methoprene, cyromazine, lufenuron, difiubenzuron, fluazuron, dicydanii and fluazuron,
- insect growth regulator such as pyriproxifen, methoprene, cyromazine, lufenuron, difiubenzuron, fluazuron, dicydanii and fluazuron
- the pesticide is an antihelminthic such as, tmtdacloprid, rotenone, magnesium flurosilicate, piperonyl butoxide, spinosyns and benzimidazoles such as albendazole, oxfenbendazole, fenbendazole.
- an antihelminthic such as, tmtdacloprid, rotenone, magnesium flurosilicate, piperonyl butoxide, spinosyns and benzimidazoles such as albendazole, oxfenbendazole, fenbendazole.
- the pesticide may be an immunomodu!ator, for example leva mi sole.
- the pesticide may be a pro-insecticide being a compound that is metabolized into an active insecticide after entering the host or target insect.
- the pro- insecticide may be derived from a microbially produced compounds for example
- halogenated pyrroles an example of this class being chlorfenapyr.
- the pesticide may be encapsulated or micro-encapsulated in one or more encapsulating or coating agents in order to more effectively control the delivery of the pesticide to the animal.
- the encapsulating or coating agent may be chosen such that if regulates th release of the pesticide once it has been deposited onto the skin or absorbed into the blood stream or lymphatic system of the animal.
- the active agent is a vaccine or immunogenic compound.
- the dosage projectile may further include one or more adjuvants.
- the vaccine my be a vaccine for Foot and Mouth, Bovine Tuberculosis,
- the health supplement may be a vitamin or mineral, for example calcium, potassium, iron, thiamine and Vitamin B12.
- active agent is a contraceptive.
- the active agent may be present in any suitable solvent or liquid, such as, isopropy! alcohol; dipropylene glycol methyl-ether; butylated hydroxytoluene dipropylene glycol monomethyl-ether; methylene chloride; diethyl ether, ethanol, acetonitrile, ethyl acetate, benzyl alcohol and a combination of natural oils.
- solvent or liquid such as, isopropy! alcohol; dipropylene glycol methyl-ether; butylated hydroxytoluene dipropylene glycol monomethyl-ether; methylene chloride; diethyl ether, ethanol, acetonitrile, ethyl acetate, benzyl alcohol and a combination of natural oils.
- the dosage projectile further includes a transdermal carrier.
- the transdermal carrier may be selected from tsopropyf alcohol; dipropylene glycol methyl- ether; butylated hydroxytoluene dipropylene glycol monomethyl-ether; methylene chloride; diethyl ether, ethanol, acetonitrile, ethyl acetate, benzyl alcohol and a combination of natural oils, ethylene glycol, propylene glycol, dimethyl polysi!oxane (DMPX), oleic acid, caprylic acid, 1-octanol, ethanol (denatured or anhydrous), liposomal compositions, suitable plant oils, such as Aloe vera derivatives or sesame seed oil or derivatives thereof, acrylic polymers, rubber-based polymers, polysiioxane-based polymers, poiyvinylpyrrofidone- based polymers, dimethyisulfoxide (D
- a dosage projectile according to the first aspect in a method of treating an animal.
- the animal may be ovine, bovine, equine, leporine, porcine, feline, canine, caprine or avian.
- the animal is bovine.
- the dosage projectile can be formulated to treat target pests such as horn fly, face fly, stable fly, heei fly, warble fly, bot fly, house fly, horse fly, deer fly, blow fly, mosquito, midge, louse, tick, and mite.
- target pests such as horn fly, face fly, stable fly, heei fly, warble fly, bot fly, house fly, horse fly, deer fly, blow fly, mosquito, midge, louse, tick, and mite.
- the target pest may be a helminth such as a roundworm, stomach worm, tapeworm, or fluke.
- the target pest may be a protozoan such as a coccidian.
- the target pest may be a larvae, pupae or egg.
- the dosage projectile can be formulated for vaccine delivery, providing health supplements, and the like.
- the term 'active agent' is Intended to have the broadest meaning and includes at least one of any therapeutic, prophylactic, vaccine, antigenic, pharmacological, anti infective (antibiotic or antiseptic) or physiologically active substance, which is deliverable to an animal to produce a desired, usually beneficial, effect. More specifically, the term 'active agent' is used herein to refer to any active agent that is capable of producing a
- active agents can be used singularly or in combinations and mixtures as required.
- the term 'pest' refers to any organism or microorganism that negatively affects an animal by colonisation, infection or transient, periodic or continual association with the animal.
- the term 'pest' includes organisms that spread disease and/or compete with an animal for nutrients.
- a pest is any organism or microorganism known to associate with an animal and which, as a result of that association , causes a detrimental effect on the animal's health and vigour.
- the term 'pest' refers to an individual pest organism or microorganism or a population of pest organisms or microorganisms.
- the term 'pesticide' refers to any substance that can be used in the control of a pest, that is, a pesticide is any substance that can prevent association of a pest with an animal, destroy or repel a pest, or mitigate the effect of a pest on an animal.
- a pesticide is any substance that can prevent association of a pest with an animal, destroy or repel a pest, or mitigate the effect of a pest on an animal.
- the term 'pesticide' also refers to naturally occurring and synthetic chemicals and chemicals synthetically derived from naturally occurring compounds.
- 'remote delivery refers to any method of delivering a pesticide to an animal which does not require immediate proximity to the animal.
- the term 'animal' is to be accorded its widest meaning, and includes humans and individuals of any species of social, economic or research importance including but not limited to members of the genus ovine, bovine, equine, porcine, feline, canine, primates (including human and non-human primates), rodents, murine, caprine, leporine, and avian.
- the animal is a bovine animal.
- the present invention provides dosage projectiles that shatter on impact with an animal to produce fragments that remain associated with the animal to mark the impact site.
- the invention also provides methods of using the dosage projectiles for treating animal.
- the dosage projectiles of the invention are made from a substance such as, but not limited to, hydrophilic colloidal materials such as, gelatin, albumin, gum arabic, alginate, casein, agar or pectins, or combinations thereof.
- the projectile can also be made from a synthetic organic compound such as, but not limited to, polystyrene, polypropylene, polyethylene, polycarbonate, polyamide. , polyviny!chtoride, resinous compounds such as fibreglass or Perspex derivatives, thermoplastic polyesters such as polylacttc acid, thermoplastic starch polymer blends, or combinations thereof.
- any known plasticized gelatine and sugar alcohol may be suitable.
- the sugar alcohol may be selected from the group consisting of glycol, glycerol, erythntoi, threitol, arabitol, xylitol, ribitol. mannitol, sorbitol, gaiactitoi, fucitol, iditol, inositol, exigmitol, isomalt, maltitol, lactiiol, maltotriitol, maltotetraito!, and palyglycitol.
- the anhydrous shell composition may comprise from about 20% to 70% of a polyol or polyol blend, including but not limited to, glycerol, maltitol, xylitol, sorbitol, sorbitan, propylene glycol, polyethylene glycol, and mannitol.
- a polyol or polyol blend including but not limited to, glycerol, maltitol, xylitol, sorbitol, sorbitan, propylene glycol, polyethylene glycol, and mannitol.
- the anhydrous shell composition may comprise from about 20% or 25% or 30% or 35% or 40% or 45% or 50% or 55% or 80% or 65% or 70% of a polyol or polyol blend, including but not limited to, glycerol, maltitol, xylitol, sorbitol, sorbitan, propylene glycol, polyethylene glycol, and mannitol.
- a polyol or polyol blend including but not limited to, glycerol, maltitol, xylitol, sorbitol, sorbitan, propylene glycol, polyethylene glycol, and mannitol.
- the gelatin polymer composition may contain from about 1 % to 5% additives including colorants, opacifiers, lubricants, and antifoam agents.
- the gelatin polymer composition may contain from about 1% or 2% or 3% or 4% or 5% additives including colorants, opacifiers, lubricants, and antifoam agents.
- inclusion of the sugar alcohol and a gelatine polymer in the projectile shell preferably results in a frangible shell that is adapted to shatter on impact with the animal to produce a plurality of shell fragments that leave a mark on the skin, fur or coat of an animal.
- the mark formed by the projectile on the animal is typically temporary.
- the mark can remain on the animal for a period of a few minutes to about 72 hours.
- the mark can remain on the animal for a period of a few minutes, a few hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours, 54 hours, 60 hours, 66 hours or 72 hours.
- the frangible shell may contain or be coated with a marker materia!.
- the marker may be a pharmaceutically acceptable dye, coloured paint, fluorescent, reflective, refractive or luminescent material.
- the dye or marker may be brightly coloured to allow a person administering the treatment to see readily which animals have been treated.
- the marker may be a pharmaceutical, food, or cosmetic colorant, oil based paint or colorant, pigment, or dye.
- suitable marking components include liquid dyes, powder dyes, water soluble dyes, infra-red dyes, ultraviolet dyes, or dyes that glow in the dark (eg chemituminescent dyes or phosphorescent dyes).
- the marker may be fluorescent or luminescent, rendering animals which have been marked or treated under low-light conditions easily visible.
- the marker and/or solution may also contain a radioactive or other suitable tracking component.
- the marker may be present as a coating on at least part of the projectile, as part of the projectile shell or as a component of the composition part of the contents of the projectile.
- the projectile may be painted with a coloured paint or dye.
- the composition used to make the projectile shelf may include for example a dye or luminescent, fluorescent, refractive or reflective material.
- the dosage projectiles of the invention include a biologically active agent.
- the active agent can be formulated for topical use or systemic use.
- the active agent can be encapsulated in a controlled-release coating prior to inclusion in the projectile thereby allowing the controlled release of the active agent on or in an animal to be treated .
- the controlled-release coating may be selected from controlled release compositions known in the field.
- the dosage projectiles of the invention typically include an active agent, and Optionally a transdermal carrier.
- the active agent can be encapsulated in a eontroiled- release coating prior to inclusion in the projectile thereby allowing the controlled release of the active agent within an animal to be treated, once it has passed transdermal ⁇ into the blood or lymphatic system of the animal.
- the controiled-re!ease coating may be selected from controlled release compositions known in the field.
- the invention is especially suited to delivering systemic treatments for the treatment of endoparasites or ectoparasites to animals.
- the active agents may be absorbed by and distributed through the blood or lymphatic system of an animal once it has been absorbed though the skin of an animal.
- the active agents are deliverable to animals by absorption through the skin, and not necessarily by a piercing element or needle, so that animals may be treated systemically, substantially without insulting the skin of the animal.
- the viscosity of the projectile contents should be such that the contents do not run off the skin, fur or coat of the animal prematurely before treatment has occurred.
- the projectile may also include a thickening agent, such as a starch-like compound, inert polymer, gel, or an oil-based composition such as sesame seed oil, if required.
- the active agent or agents contained in the projectile can be in different forms and/or concentrations, depending on the formulation, the carrying capacity, and solubility and release characteristics desired, for example as neutral molecules, components of molecular complexes, and pharmaceutically acceptable salts, free acids or bases, or quaternary salts thereof.
- Simple derivatives of the active agents mentioned herein, such as pharmaceutically acceptable ethers, esters, amides and the like which have desirable retention and release characteristics in vivo, and enzymes, pro-active forms, pro-drugs and the like, can also be employed as required.
- the amount of active agen to be complexes with the transdermal carrier will vary depending on the particular active agent, the desired therapeutic effect, and the time span for which the active agent is to be therapeutically effective. Normally, the amount of active agent in the transversal system can vary from about 0.1 % to about 50% or even from about 0.1% to about 30% by weight based on the dry weight of the total carrier composition.
- the preferred amount need only be for example from about 0.1 % to about 10%.
- the active agent is an anti-infective or health supplement such as a mineral or vitamin
- other active agents or specific pesticide drug which may be employed more specifically in embodiments of the invention include, but are not limited to: Macrocyc!ic Lactones including the ave mectins and milbemycins, for example ivermectin, eprinomectin, moxidectin, selamectin, doramectin, milbemycin, abameetin, cydectin and emamectin benzoate,
- Synthetic pyrethroids such as cyhalothrin, lambda cyhalothrin, gamma cyhalothrin, fiumethrin, delta methrin, cypermethrin, cyfluthrin, fenvalerate, aiphacypermethrin and pyrethrin.
- insect Growth Regulators such as yriproxifen, methoprene, cyromazine, lufenuron, diflubenzuron, fluazuron, dicyclanil and fluazuron.
- anthelmintics and immunornodulators e.g. Levamisole.
- the active agent is a transdermal immunization composition, including Vibrio cholera toxin, tetanus toxoid, bacterial ADP ribosylating exotoxin (bARE), Foot and Mouth Disease antigens, tuberculosis antigens, and/or Escherichia colt heat-labile enterotoxin, and/or mutants and derivatives thereof. It also includes a mixture of any such transdermal immunization compositions and/or other medicaments.
- the transdermal immunization compositions or mixtures thereof may be made up in any suitable solvent or liquid, such as, but not limited to, water or alcohol.
- the transdermal immunization compositions can further serve as transdermal carriers in their own right, in that they facilitate the dermal penetration of other active agents, compositions, polypeptides, oligopeptides, or peptide fragments,
- the active agents can include steroid hormones such as estrogens, for example coipormon, conjugated estrogens, estradiol and estradiol esters (e.g. acetate, benzoate. cypionate, dipropionate diacetate, enanthate, undecylate and valerate), estriol, estrone, ethinyl estradiol, equiienin, equilin, mestranoi, moxestro!, mytatrienediot, qutnestradio!
- estrogens for example coipormon, conjugated estrogens, estradiol and estradiol esters (e.g. acetate, benzoate. cypionate, dipropionate diacetate, enanthate, undecylate and valerate), estriol, estrone, ethinyl estradiol, equinousn, equilin, mestranoi, moxestro!, mytatrienedio
- progestagenica!ly effective steroid hormones such as aliyiestrenol, anagestone, chtormadinone acetate, delmadinone acetate, demegestone, desogestre!, 3-keto desogestrei, dimethisterone, dydrogesterone, ethiny!estrenol, ethisierone, ethynodioS (and diacetate), flurogestone acetate, gestodene, gestonorone caproate, haloprogesterone, ⁇ 17- hydroxy- and 17-acetate-) 16-methylene-progesterone, 17a ⁇ hydroxyprogesterone (acetate and caproate), levonorgestrei, lynestrenoi, medrogestone, medroxyprogesterone (and acetate), megestrol acetate, melengestroi, norethindrone (acetate and enanthate), noreth
- norethandfOlone norethandfOlone, normethandrone, oxandrolone, oxymesterone, oxymethoione, prasterone, stanlolone, stanozolol, testosterone (acetate, enanthate, i sob uty rate, propionate and undecanoate), testosterone-17-chloral hemi-acetai, testosterone-17 ⁇ -cypionate, or tiomesterone.
- Anaesthetic agents and analgesics such as benzocaine, bupivicaine, capsaicin, cocaine, dibucaine, dyclonine, etidocaine, ltdocaine, mepivacaine, prilocaine, procaine and tetracaine, acetaminophen, acetyl sal icy lie acid, buprenorphine, codeine, fentanyl, hydromorphone, lisuride, salicylic acid derivatives, sufentanil and sumatriptan.
- analgesics such as benzocaine, bupivicaine, capsaicin, cocaine, dibucaine, dyclonine, etidocaine, ltdocaine, mepivacaine, prilocaine, procaine and tetracaine, acetaminophen, acetyl sal icy lie acid, buprenorphine, codeine, fentanyl, hydromorphone
- Antibacterial or antibiotic agents such as aminoglycosides, ⁇ -iactams, cephamycins, macrolides, penicillins, polypeptides and tetracyclines.
- Anthelmintic, anti-trematodal, anttcestodal, or anti-parasitic parasiticidat agents such as albendazole, levamisole. mebendazole, pyrantel, praziquantel, moxidectin, ivermectin, oxamniquine, metrifonate, piperazine, thiabendazole, tiabendazole, dieihylcarbamazine, pyrantel, niclosamide, doramectin, eprinomectin, morantei, oxfendazole, dichlorvos, c forsuton and selamectin.
- albendazole levamisole. mebendazole, pyrantel, praziquantel, moxidectin, ivermectin, oxamniquine, metrifonate, piperazine, thiabendazole, tiabendazole
- Acaricidal agents including antibiotic acaricides, nikkomycins, thuringiensin, macrocyc!ic lactones, acaricides, tetranectin, bridged dipheny! acaricides, azobenzene, benzoximate, benzyl benzoate, bromopropylate, chlorbenside, chlorfenethol, chlorfenson, chlorfensulphide, chlorobenziiate, ch!oropropylaie, cyf!umetofen, dicofol, diphenyl suifone.
- pyrtmidinamine acaricides pyrimidifen, pyrrole acaricides, chlorfenapyr, quinoxaline acaricides, chinornethionat, thioquinox, sulfite ester caricides, propargite, tetrazine acaricides, clofentezine, diflovidazin, tetronic acid acaricides, spirodictofen, thiocarbamate acaricides, fenothiocarb, thiourea acaricides, chloromethiuron, diafenthiuron, unclassified acaricides, acequinocyl, amidoflumet, arsenous oxide, bifenazate, closanteL crotamiton, disulfiram, etoxazole, fenazaflor, fenazaquin.
- fenpyroximate f!uacrypyrim, fluenetii, mesulfen, fvlNAF, nifluridide, pyridaben, sulfiram, sulfluramid, sulfur triarathene.
- Anti-fungal agents such as ciortrimazole, ketoconazole, miconazole, nystatin and triacetin.
- Antihistamine agents such as tricyclics such as ahistan, etymemazine, fenethazine, n-hydroxyethylpromethazine chloride, isopromethazine, mequitazine, promethazine, pyrathiazine, and thiazinamium methyl.
- Anti-inflammatory and/or corticoid agents such as beclomethasone, betamethasone (and acetate, diproprionate and valerate), corticosterone, cortisone, deoxycortocosterone (and acetate), dexarneihasone, diclofenac, fenoprofen, flucinolone (and acetonide), fludrocortisone, fiuocinonide, f!uniso!ide, f!uradrenotide, flurbiprofen, halcinonide, hydrocortisone (and acetate), ibuprofen, ibuproxam, tndoprofen, ketoprofen, ketorolac, naproxen, oxametacine, oxyphenbutazone, piroxicam, prednisolone, prednisone, suprofen and triamcinolone (and acetonide).
- beclomethasone betamethasone (
- Antiviral agents such as acyclovir, rimantadine and vidarabine.
- Anxiolytic agents such as azapirones such as buspirone and ipsapirone,
- benzodiazepines such as alprazolam, chlordiazepoxide, clonazepam, clorazepate, diazepam, flurazeparn, halazepam, !orazepam, oxazepam, oxazolam, prazepam and triazolam,
- p-Adrenergic agonist agents such as albuterol, carbuterol, fenoterof, metaproterenol, mirtazapine, rimiterol, quinterenol, salmefamoS, soterenol, tratoquinol, terbutaline and terbuterof.
- Bronchodilators such as ephedrine derivatives including-.
- Anti-allergy agents such as amlexanox, astemizole, azelasttne, cromolyn, fenpiprane, ibudilast, nedocromii, oxatomide, pentigetide, repirinast, tranilast and traxanox.
- Cardioactive agents such as atenolol, benzydroftumethiazide, bendroflumethiazide, calcitonin, captopnl, chlorothiazide, clonidine, clopamide, dobutamine, dopamtne, diltiazem, ena!april, enalaprilat, gailopamil, indomethactn, isosorbide (dinitrate and mononitrate), monoxidii, nicardipine, nifedipine, nitroglycerin, papaverine, prazosin, procainamide, propranolol, prostaglandin and E 2 , quinidine.
- cardioactive agents such as atenolol, benzydroftumethiazide, bendroflumethiazide, calcitonin, captopnl, chlorothiazide, clonidine, clopamide, dobutamine
- Central Nervous System stimulants and agents such as dextroamphetamine, methy!phenidate, and nicotine.
- Cholinergic agents such as acetylcholine, arecoline, bethanechol, carbachol, choline, methacoline. muscarine and pilocarpine.
- Anti-cholinergic agents such as atropine, eucatropine and procyclidine.
- Anti-emetic agents such as acetylieucine monoethanolamine, alizapride,
- benzquinamtde bietanautine, bromopride, buclizine, chlorpromazine, debopride, cyclizine, dimenhydrinate, dipheniodol, domperidone, granisetron, meclizine, methal!tal,
- metoc!opramide metopimazine, nabilone, ondansteron, oxypendyl, pipamaztne, piprinhydrinate, prochlorperazine, scopolamine, tetrahydrocannabinols, thiethylperazine, thioproperzaine, trimethobenzarnide and iropisetron.
- Muscle relaxants such as Baclofen.
- Th projectiles may have sufficient volume to contain a unit dosage for a certain disease for an animal.
- the dosage is typically calculated to correspond to a certain minimum weight of animal to which an active agent is to be administered, if larger animals need to be treated, the number of projectiles launched at the animal may be increased accordingly.
- a single projectile containing a unit dosage may be enough.
- two projectiles may be required.
- the amounts of the active agent used in a projectile may be determined by methods known to persons skilled in the field of the invention. Amounts typically range from about 0.05 mg to about 20,000 mg and preferably from about 0.1 mg to about 1 ,000 mg, depending on the active agent, the disease to be treated, the animal species, and the size of the animal. In certain embodiments of the invention, the active agents may be included in a range from about 0.1 to about 500 mg per mammal per 50 kg body weight.
- the transdermal carrier is typically used in an amount of about 5% to about 95%, and preferably from about 10% to about 75%, by weight based on the dry weight of the total carrier composition.
- the transdermai carrier composition of the present invention can also contain one or more solvents and/or co-solvents known in the art.
- Suitable solvents and co-solvents include volatile substances or compositions such as alcohols, aromatic hydrocarbons such as benzene derivatives, lower molecular weight a!kanes and cycloalkan.es, aikanoic acid esters, polyhydric alcohols, which include glycols, triofs and polyols such as ethylene glycol, diethy!ene glycol, propylene glycol, dipropylene glycol, trimethylene glycol, butylene glycol, polyethylene glycol, hexylene glycol,
- glycol ethers such as ethylene glycol monoethyi ether, glycol esters, glycol ether esters such as ethylene glycol monoethyi ether acetate and ethylene glycol dtacetate
- saturated and unsaturated fatty acids mineral oil, silicone fluid, lecithin, retinol derivatives and the like, water, and ethers, esters and alcohols of fatty acids or combinations and mixtures thereof.
- solvents and co-solvents that may be used in the carrier composition depends on the nature and amount of the other ingredients, such amount typically ranges from about 0.1% to about 40%, and preferably from about 0.1 % to about 30% by weight, and more preferably from: about 1% to about 20%, by weight based on the dry weight of the total carrier composition.
- the transdermal carrier is typically selected so that it may be readily absorbable by the skin of an animal without causing undue itching, irritation, or toxic effects to the animal. Selection of the transdermal carrier will also depend on the active agent to be delivered to an animal and also the type of animal to be treated, or the intended delivery site on an animal. Thus, the transdermal carrier composition 16 may be selected to suit the charge, size, hydrophobicity, hydrophilicity, amphipathicity, pi, pH, decay rate, or other relevant criteria of the active agent to be carried transdermal! ⁇ while also being readily absorbable through the skin of an animal.
- the dosage projectile further includes a transdermal carrier as defined in WO 2008/052263 assigned to SmartVet Pty Ltd.
- the pesticide may be transported (with the aid of a transdermal agent) through the skin following rupturing of the projectile upon contact with the animal, penetration of the pesticide being effected by the transdermal carrier contained within the projectile, in use the transdermal carrier facilitates passage of the pesticide through the skin of an animal in need of treatment.
- the transdermal carrier includes carriers such as isopropyl alcohol, dipropylene glycol methyl-ether, butylated hydroxytoluene dipropylene glycol monomethyi-ether, 1-methoxy 2-propanol (g!ysolv PM/lcinol P ), Ethylene glycol monobutylether (butyl glyxolv/butyl icinol), Butyl di g!ysolv (butyl-icinol), Transcutol, propylene glycol (PG), N-methyl-2 pyrrolidone (NMP), methylene chloride, diethyl ether, ethanoi, acetonitrile, ethyl acetate, benzyl alcohol and a combination of natural oils; ethylene glycol, propylene glycol, dimethyl po!ysiloxan
- DMPX oleic acid, caprylic acid, 1-octanol, ethanoi (denatured or anhydrous), liposomal compositions, suitable plant oils, such as Aloe vera derivatives or sesame seed oil or derivatives thereof, acrylic polymers, rubber-based polymers, polysiloxane-based polymers, polyvinylpyrrolidone-based polymers, dimethylsulfoxide (DMSO), dimethylformarnide (DMF), lecithin, i[g1]Any artificial vesicles which are designed to mimic a cell vesicle and deliver drugs or genetic material into a ceil.
- suitable plant oils such as Aloe vera derivatives or sesame seed oil or derivatives thereof, acrylic polymers, rubber-based polymers, polysiloxane-based polymers, polyvinylpyrrolidone-based polymers, dimethylsulfoxide (DMSO), dimethylformarnide (DMF), lecithin, i[g1]
- a Transfersome® is a bi-component, most often vesicular, aggregate.
- the main functional characteristic of the aggregate is the extreme flexibility and permeability of its bilayer-like membrane coating.
- the basis of this characteristic is the interdependency of local membrane shape and composition, which makes the bi!ayer self-regulating and self- optimising.
- the bilayer is thus capable of stress adaptation, via local and reversible bitayer component demixing, These characteristics make Transfersomes® a device suitable for non-invasive and targeted drug delivery, including across intact skin.
- Additional transdermal carriers include, but are not limited to, ethosomes, azone, castor oil derivatives, such as ethoxylated castor oil, jojoba oil derivatives, corn oil derivatives, emu oil derivatives, or any other suitable transdermal or transcutaneous carrier or carrier composition.
- castor oil derivatives such as ethoxylated castor oil, jojoba oil derivatives, corn oil derivatives, emu oil derivatives, or any other suitable transdermal or transcutaneous carrier or carrier composition.
- the transdermal carrier is propylene glycol , DMSO, alcohol or a more penetrant adjuvant known to the art.
- an enhancer is incorporated into the carrier composition.
- An 'enhancer 1 as used herein refers to substances used to increase permeability and/or accelerate the delivery of an active agent through the skin of an animal, and include monohydric alcohols such as ethyl, isopropyl, butyl and benzyl alcohols; or dihydnc alcohols such as ethylene glycol, diethylene glycol, or propylene glycol dipropylene glycol and trimethylene glycol; or polyhydric alcohols such as glycerin, sorbitol and polyethylene glycol, which enhance drug solubility; polyethylene glycol ethers of aliphatic alcohols (such as cetyl, lauryl, oleyl and stearly) including po!yoxyethylene-4-lauryi ether, polyoxyethy!ene-2-oieyl ether and po!yoxyethylene-10-oleyl ether; vegetable, animal and fish fats and oils such
- enhancers include oleic and linoleic acids, triacetin, ascorbic acid, panthenol, butyl ated hydroxyto!uene, tocopherol, tocopherol acetate, tocopheryl linoleate.
- the amount typically ranges up to about 35%, and preferably from about 0.05% to about 20%, by weight based on the dry weight of the total carrier composition.
- the dosage projectile is shot from a launching device such as a gun, pressure or gas activated launcher or the like.
- a launching device such as a gun, pressure or gas activated launcher or the like.
- suitable launching devices may be based on similar gas discharge technologies utitized in known dart guns, air guns, crowd control guns and paintball markers currently in production and used in the veterinary, security, law enforcement, hunting, and recreational shooting or paintball industry, in a preferred embodiment a launcher such as described in WO 2012/171064 assigned to Smart Vet Pty Ltd is used.
- the projectile launcher may include velocity selection means operable to select the velocity at which the projectile is launched.
- the velocity selection means may include pressure-regulating means operable to select the pressure at which the pressurized fluid is released.
- the launching propellant may be a pressurized fluid, such as gas or air.
- a user triggers the launcher which shoots the projectile at the animal with a velocity sufficient to rupture the projectile upon impact with the animal.
- This allows the contents of the projectile to contact the skin, coat or fur of the animal, allowing the active agent to be absorbed through the skin of the animal and the impact produces a plurality of shell fragments at least some of which remain associated with the skin, coat or fur of the animal to produce a mark thereby enabling the user to readily discern whether the animal has been treated, where the site of impact was on the animal (if the site of impact is important to the efficacy and absorption of a specific active agent) and whether the projectile has ruptured successfully or not.
- a marker such as coloured paint
- the mark may be easily visualised on animals with a dark coat, skin or fur.
- Th dosage projectiles may be launched with a single trigger action from a projectile launcher.
- the projectile launcher may include a selector for selecting the number of projectiles to be launched with a single trigger action.
- the projectiles may be delivered using a semi-automatic trigger action.
- the dosage projectiles when used to deliver multiple pesticides or doses, may include pesticides which are similar or differing in composition, efficacy, or pharmaceutical action. Accordingly, it is to be understood that the dose administered to an animal may be controlled by selecting the number and type of dosage forms or dosage projectiles to be launched at an antmai. in this way, a user can easily adjust the dose required for correctly dosing the animal, by compensating for the size and weight of an animal, and tailor dosing regimens.
- the treatment may be prophylactic.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Birds (AREA)
- Chemical & Material Sciences (AREA)
- Combustion & Propulsion (AREA)
- General Engineering & Computer Science (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dispersion Chemistry (AREA)
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- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201361821789P | 2013-05-10 | 2013-05-10 | |
PCT/AU2014/000501 WO2014179831A1 (en) | 2013-05-10 | 2014-05-08 | Dosage projectile for remotely treating an animal |
Publications (2)
Publication Number | Publication Date |
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EP2994115A1 true EP2994115A1 (en) | 2016-03-16 |
EP2994115A4 EP2994115A4 (en) | 2016-12-14 |
Family
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EP14794581.0A Withdrawn EP2994115A4 (en) | 2013-05-10 | 2014-05-08 | Dosage projectile for remotely treating an animal |
Country Status (3)
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US (1) | US9737386B2 (en) |
EP (1) | EP2994115A4 (en) |
WO (1) | WO2014179831A1 (en) |
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AU2015299055C1 (en) * | 2014-08-06 | 2021-05-06 | Ascendis Pharma A/S | Prodrugs comprising an aminoalkyl glycine linker |
JP5977470B1 (en) * | 2015-08-05 | 2016-08-24 | 富士カプセル株式会社 | Composition for soft capsule film |
AU2018279864A1 (en) | 2017-06-08 | 2019-12-19 | Wildlife Protection Management, Inc. | Animal control system |
AU2020229386A1 (en) * | 2019-02-27 | 2021-09-09 | Smartvet Pty Ltd | Dosage projectile and method of manufacture |
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GB1268635A (en) * | 1968-04-25 | 1972-03-29 | Scherer Ltd R P | Capsules for marking objects |
US6524286B1 (en) | 1999-03-25 | 2003-02-25 | Gordon O. Helms | Medical application system for animals |
WO2008052263A1 (en) * | 2006-11-01 | 2008-05-08 | Veterinary Encapsulation Biosciences Pty Ltd | Delivery system for remote treatment of an animal |
IT1399031B1 (en) * | 2009-11-05 | 2013-04-05 | Novamont Spa | BIODEGRADABLE ALIPHATIC-AROMATIC COPOLIESTERE |
AU2011301767B2 (en) * | 2010-09-13 | 2014-12-18 | Smartvet Pty Ltd | System for oral delivery of an agent to an animal |
-
2014
- 2014-05-08 WO PCT/AU2014/000501 patent/WO2014179831A1/en active Application Filing
- 2014-05-08 US US14/890,230 patent/US9737386B2/en not_active Expired - Fee Related
- 2014-05-08 EP EP14794581.0A patent/EP2994115A4/en not_active Withdrawn
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US20160081782A1 (en) | 2016-03-24 |
US9737386B2 (en) | 2017-08-22 |
WO2014179831A1 (en) | 2014-11-13 |
EP2994115A4 (en) | 2016-12-14 |
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